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| Sponsor: | Oncothyreon Inc. |
|---|---|
| Information provided by: | Oncothyreon Inc. |
| ClinicalTrials.gov Identifier: | NCT00522652 |
Purpose
This study is being conducted to determine the safety and biologic activity of PX-478, and to allow for observation of any preliminary evidence of antitumor activity in patients with advanced metastatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors Lymphoma |
Drug: PX-478 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
| Official Title: | A Phase 1 Trial of Oral PX-478 (a HIF-1α Inhibitor) in Patients With Advanced Solid Tumors or Lymphoma |
| Estimated Enrollment: | 45 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Investigational Drug: Experimental
Dose Escalation
|
Drug: PX-478
Oral formulation, dose escalation, taken on days 1 to 5 of a 21 day cycle until progression or development of unacceptable toxicity
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| TGen Clinical Research Services at Scottsdale Healthcare | Recruiting |
| Scottsdale, Arizona, United States, 85258 | |
| Contact: Lynne Hull 480-323-1071 lhull@shc.org | |
| Principal Investigator: Dan VonHoff, M.D. | |
| United States, Texas | |
| The University of Texas M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Hala Abdulkadir 713-792-9944 habdulka@mdanderson.org | |
| Principal Investigator: Roy S Herbst, Ph.D. | |
More Information
| Responsible Party: | Oncothyreon Inc ( Larry Romel / Sr. Director, Clinical Operations ) |
| Study ID Numbers: | PX-478-001 |
| Study First Received: | August 28, 2007 |
| Last Updated: | February 3, 2010 |
| ClinicalTrials.gov Identifier: | NCT00522652 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
cancer advanced cancer lymphoma |
|
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma |